The Medical device industry in India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945. The Central Drugs Standard Control Organization i.e CDSCO is the national regulatory body for Indian medical devices and pharmaceuticals. It’s a licensing authority. It approves any new chemical entity (drug) which is to be imported to India.
The CDSCO is responsible for regulating the registration & sale of notified medical devices in India. Every nation under its Ministry of Health will have a dedicated governing body to look after every aspect of pharmaceutics and medical devices.
We also help companies get the wholesale license to facilitate the sale of their products in India. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals & medical devices.
CDSCO is controlled and governed by Directorate General of Health Services which comes under the ministry of health and family welfare, Government of India. Every nation under its Ministry of Health will have a dedicated governing body to look after every aspect of pharmaceutics and medical devices.
The headquarter of the Central Drugs Standard Control Organization is located in New Delhi.
CDSCO has six zonal offices, four sub-zonal offices, thirteen Port offices and seven laboratories spread across the country.
Roles of CDSCO
- Approval of new drugs and clinical trials.
- Import registration & licensing.
- Licensing of blood banks, vaccines and some medical devices.
- Amendment to Drugs & Cosmetics Act and rules.
- Participation in WHO GMP certification schemes.
- Grant to test license, personal license, NOC’s for export.
- Testing of drugs by central labs
Medical Device Registration and CDSCO approval process in India
Step 1: Is your product on the list of Notified Medical Devices and IVDs which require device registration in India?
The following are the notified medical devices :
Blood Component Bags, Blood Grouping Sera, Bone Cements, Cardiac Stents, Catheters, Condoms, Disposable Hypodermic Needles, Disposable Hypodermic Syringes, Disposable Perfusion Sets, Drug Eluting Stents, Heart Valves, IV Cannulae, Internal Prosthetic Replacements, Intra Ocular Lenses, Intra Uterine Devices, IVD Devices for HIV, HBsAg and HCV, Orthopedic Implants, Scalp Vein Sets, Skin Ligatures, Surgical Dressings, Sutures and Staplers, Tubal Rings, Umbilical Tapes.
Step 2: If your medical device or IVD product is included in the above-notified list, Then as per the process you should firstly appoint an India Authorized Agent to interact with the Central Drugs Standard Control Organization (CDSCO) on your behalf. Your Agent must have a valid wholesale license (Forms 20B and 21B).
Step 3: Medical device or IVD on the list above, grant your India Authorized Agent Power of Attorney to manage your registration in India.
Step 4: Medical device or IVD on the list above, file application for Device Registration Certificate to CDSCO using Form 40. Schedules D-1 and D-2 must be included, as well as verification of compliance with US, Canadian, European, Japanese or Australian medical device regulations
Step 5: Medical device or IVD on the list above, device manufacturers new to India require a Form 45 (New Drug License) in support of the Form 40 application.
Step 6: Medical device or IVD on the list above, obtain Registration Certificate Form 41 from CDSCO. The certificate is valid for up to 3 years.
Step 7: Identify your distributor in India (holding forms 20B and 21B).
Step 8: Apply for Import License using Forms 8 and 9 available from CDSCO. You must identify your chosen distributors on these forms.
Step 9: Obtain Import License (Form 10) from CDSCO and CDSCO License is valid for up to 3 years.
Step 10: You are now authorized to market your device in India.